Aloe Vera

PEP Topic

Radiodermatitis

Description

Aloe vera is a fleshy green cactus plant. A gel made from the plant is used as a complementary therapy for dry skin, cuts, and burns. Aloe vera gel may provide a protective effect on skin with increasing cumulative uses. It is described as having anti-inflammatory and antibacterial properties. It may reduce vasoconstriction and leukocyte and platelet aggregation at the site of injury. It is known to improve wound oxygenation, increase the rate of collagen formation, and decrease the amount of dead tissue at the wound site. Aloe vera preparations have been studied for radiodermatitis and mucositis.

Weekly assessments were performed using the Radiation Therapy Oncology Group (RTOG) scale.

Skin changes recorded were itching, skin texture, tanning, erythema, time to skin change, and dose at first skin change.

Results:

Aqueous cream was significantly better than aloe vera gel in reducing the incidence of dry desquamation and moderate or higher pain (p < 0.001). Participants with cup size D or more in either treatment arm experienced a significantly greater incidence of moderate or higher erythema compared with smaller-breasted women (p < 0.02). For non-chemotherapy participants, the aloe vera arm experienced a significantly reduced incidence of moderate or higher erythema (p = 0.02). The control group arm experienced a significantly reduced incidence of moderate or higher pain (p = 0.03). The most important predictors of development of skin reaction were radiation dose, breast size, patient smoking, and damage to the lymphatic system manifested by one or more lymphocele drainage. Cumulative dose was greater than 2,700 cGy, and there was a delay to onset of erythema (p = 0.013).

Conclusions:

Aqueous cream is superior to aloe vera in reducing the acute RT skin reactions of dry desquamation and pain.

Limitations:

The consistency and appearance of the two study preparations were quite dissimilar, so participants may have guessed the identity of their study preparation.

Ninety percent of the final skin assessments were conducted over the telephone, so the research nurse was not able to view the participant’s skin and had to rely on the subjective assessment.

Study Purpose:

To test the hypothesis that the use of aloe would lead to a one-point reduction in radiation-induced skin rash (RISR) severity and a decrease in symptom severity compared to a traditional dry powder skin care regimen

Intervention Characteristics/Basic Study Process:

Potentially eligible patients underwent a skin test to rule out allergic reactions. Informed consent was obtained, and patients were randomized to each arm (aloe, placebo cream, or control powder). The creams were dispensed in identically labeled containers to the patients with study protocol directions. Two radiation oncology nurses trained to identify RISR assessed acute skin reactions and completed scoring at weeks 1, 2, and 4. All patients were asked to either use no soap or mild soap and to apply baby powder or cornstarch to the treatment skin markings. Patients in the powder arm applied powder during treatment followed by one month of a moisturizing cream. Those in the cream arm applied it three times per day throughout treatment and for one month after completion. Additional treatment for moist desquamation and other skin reactions was administered according to individual physician preferences.

Sample Characteristics:

N = 237

AGE = > 18 years

FEMALES: 100%

KEY DISEASE CHARACTERISTICS: Nonmetastatic breast cancer

OTHER KEY SAMPLE CHARACTERISTICS: Previous mastectomy or segmented resection; agreement to comply with the study protocol; received either 45 Gy in 20 fractions or 50 Gy in 25 fractions; approximately 40% were current smokers

Setting:

SITE: Single-site

SETTING TYPE: Outpatient

LOCATION: Canada

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment

Study Design:

Single-blinded, placebo-controlled, randomized trial

Measurement Instruments/Methods:

Modified 10-point Catterall skin scoring profile

Results:

Patients were studied during a 21-month period. Ten withdrew before the start of the study, and one withdrew because of a selection error. Skin rashes occurred in all three arms with the greatest number of skin rashes noted in the aloe cream arm (31% compared to 15.6% with a placebo). Skin reaction scores were consistently higher with aloe than with the standard treatment of powder (p < 0.02). The study also showed that patients in the powder arm reported more dryness, pain, and itching (p = 0.0163). This study did not meet the endpoint of a change in the RISR severity of one point. Women with breast cup sizes C and greater experienced a significantly higher severity of skin reactions (p < 0.02). It also was noted that erythema and dry desquamation occurred more with powder, and moist desquamation (< 50%) occurred most with aloe cream and (> 50%) occurred most with powder.

Conclusions:

The results of the study showed that known-quality aloe or placebo creams did not improve skin reactions or symptoms; they made them worse. The study also concluded that dry skin was better than moist treatment during radiation treatment.

Limitations:

Baseline sample/group differences of import

Measurement/methods not well described

Other limitations/explanation: The treatment of moist desquamation was not standardized, so physicians could order whatever was deemed medically necessary. The study did not disclose whether any of the study patients fell into that category. A significantly higher proportion of patients in the aloe and placebo arms received chemotherapy as well. It appears that radiation therapy did not employ intensity-modulated radiation therapy. The use of powder on the skin is not common as a standard of practice.

Nursing Implications:

Patient education is very important, and patients should be instructed to use only skin care products that will be effective in managing radiodermatitis. This study had some limitations, but it adds to the growing body of evidence that aloe can make radiation skin reactions worse. Patients should be instructed to not use aloe products on their skin.

Study Purpose:

To compare an anionic polar phospholipid (APP)–based cream and an aloe vera–based gel to determine their effectiveness in preventing and treating radiodermatitis.

Intervention Characteristics/Basic Study Process:

The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by a radiation oncologist. Follow-up examinations were done four to six weeks after the completion of radiation therapy (RT).

Setting:

St. Jude Children’s Research Hospital, Memphis, Tennessee

Study Design:

The study used a quasiexperimental design. Patients served as their own controls.

Measurement Instruments/Methods:

The primary endpoint was skin care failure, which included moderate to severe dryness, pruritus, erythema, and dry desquamation. Skin comfort assessment was completed by the patient or his/her parent and consisted of 15 items on a four-level scale. Dermatologic assessment included a questionnaire of negative items and was completed by nursing staff. The National Cancer Institute (NCI) Common Terminology Criteria (CTC) for adverse events involving the skin used a grade 1 to 5 scale.

Intervention Characteristics/Basic Study Process:

Participants were randomized to use aloe vera gel and mild soap or mild soap alone. The skin care regimen began on the first day of treatment. Aloe was to be applied liberally after treatment each day, reapplied throughout the day, and rinsed off prior to treatment (no time frame identified). Assessments were performed on day 1 and in weekly reviews. Clinicians could order supplemental skin products as they deemed necessary.

Sample Characteristics:

The sample was comprised of 70 patients (34% male, 48% female).

Age was: 45 years (18% in each study group), 45–59 years (55% aloe/soap; 32% soap alone), and older than 59 years (27% aloe/soap; 50% soap alone).

Patients had cancer of the head and neck (39%), chest (58%), and extremities (3%).

Study Purpose:

To determine if aloe vera gel can prevent the development of radiodermatitis in patients undergoing breast radiation therapy (RT).

Intervention Characteristics/Basic Study Process:

In both studies, gels were applied twice a day starting within three days of RT initiation. Each patient received instruction on skin care. Patients were stratified by age groups: younger than 45 years, 45 to 60 years, and older than 60 years.

Sample Characteristics:

Study 1 included 194 patients.

Study 2 included 108 patients.

Patients were younger than 45 years (21.5%), 45 to 60 years (35%), or older than 60 years (43.5%).

All patients were women.

Patients had breast cancer.

Patients were not receiving concomitant chemotherapy, and there were no scars or ulcers in the treatment field.

Study Design:

Two studies were reported: a randomized, double-blind, controlled trial of aloe versus placebo gel and a randomized trial of aloe versus no treatment.

Measurement Instruments/Methods:

Patients were rated by an MD/RN on scale of 0 (normal) to 3 (moist desquamation and/or ulceration).

Patients self-rated on the same scale and completed questionnaires at the start and weekly until one month post RT.

Kaplan-Meier curves and log rank test were used to compare treatment arms.

Literature Evaluated:

Thirty-one references were retrieved. Literature was evaluated on the basis of sample size. Meta-analysis was performed on studies reporting at least grade II skin toxicity.

Sample Characteristics:

The final number of studies included was 31.

The sample size across studies was 3,174 participants (range 413–506).

Participants had various tumor types.

All participants received radiation therapy (RT).

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Results:

Findings were reviewed for washing, topical aloe vera, topical sucralfate, Biafine cream, corticosteroids, hyaluronic acid, barrier film, dressings, and wheatgrass extract for prophylaxis. For management, interventions included were topical steroid cream, sucralfate, and dressings. Meta-analysis across studies using any topical prophylaxis showed that any intervention was associated with lower odds of development of skin toxicity (p = 0.02). There were no significant results for management interventions. There was consistent evidence in favor of gentle washing with mild soap during RT. There was some evidence in support of corticosteroids, bepanthan, topical hyaluronic acid, calendula, and barrier films. Aloe vera was associated with higher toxicity.

Conclusions:

Evidence did not support the use of sucralfate, Biafine, or dressing for prevention. Evidence regarding interventions for management of skin toxicity was conflicted, and none produced significant effects. Findings support the use of washing. There was some evidence in support of using corticosteroids, bepanthan, barrier films, calendula, and topical hyaluronic acid. Findings suggest that use of any topical therapy for prophylaxis may be more effective than no intervention.

Limitations:

Analysis was limited by combining all types of interventions together, which did not allow for differentiation between those agents individually shown to be effective and not effective.

Methods for evaluation of the quality of the research were not well described or incorporated into the analysis.

Findings regarding management were questionable because of high heterogeneity among studies included in the meta-analysis.

Actual odds ratios or effect sizes from the meta-analysis were not reported.

Final recommendations stated by the authors were not consistent with the rest of the conclusions stated elsewhere in the article.

The basis for recommendations, concerning evaluation of the quality of the evidence, was not clear.

The authors stated that they weighted studies by sample size, but this method was not described.

Nursing Implications:

Washing during RT should not be restricted. There is some evidence in support of using calendula, hyaluronic acid, no-sting barrier film, bepanthan, and topical steroids. Evidence does not support the use of aloe vera.

Purpose:

To review the evidence for approaches to prevention and management of radiodermatitis

Search Strategy:

Databases used were MEDLINE, PubMed, and Cochrane Library. Keywords searched were skin reactions, radiation, radiation adverse effects, erythema, desquamation, and radiodermatitis. Studies were included in the review they

Were published reports or abstracts from January 1, 2000 to October 1, 2008.

Reported the method of skin grading.

Studies were excluded from the review if they were letters, comments, editorials, case reports, practice guidelines, systematic reviews, or meta-analyses.

Literature Evaluated:

The total references retrieved and the quality rating approach were not reported.

Conclusions:

There is lack of support for Biafine use. There is some evidence to suggest that topical corticosteroids may be beneficial. Evidence for non-steroidal topical agents is conflicting. Evidence does not support use of Aloe Vera or sucralfate cream. Some evidence to suggest that light-emitting diode, pentoxifylline, sliver-leaf dressings, washing, zinc supplements and intensity-modulated radiation therapy are beneficial.

Limitations:

The trials were small and had numerous design and reporting limitations.

Secondary trials evaluated the same agent or treatment, making comparison very difficult.

Nursing Implications:

Further research is needed in this area. Intervention goals, prevention or treatment need to be clear and further work is needed to develop and validate more sensitive assessment tools. Further work is also needed to evaluate differences in risk based on anatomical sites.

Search Strategy:

Experts working in the area were contacted and asked for published and unpublished controlled clinical trials and their own papers and files. All databases were searched from their inception to May 1998.

Studies were included if they were controlled clinical trials.

Studies were excluded if they were not performed on aloe vera mono-preparation and if they were designed only on a certain pharmacologic constituent of the aloe vera plant.

Data were extracted in a predefined fashion, and the methodologic quality of the study was assessed using the Jadad scoring system.

Literature Evaluated:

Ten trials met the inclusion criteria and were included. Three clinical studies were excluded because of not being performed on aloe vera mono-preparation or use of only a constituent of the plant. No unpublished studies were found.

Aloe vera was used as as a topical agent in six studies and was administered orally in four studies. Of these studies, two examined topical aloe vera for prevention or mitigation of radiodermatitis.

Results:

In the studies regarding use for radiodermatitis, no difference was reported between the treatment group and the placebo group.

Aloe vera might be useful in patients after dermabrasion, mild to moderate plaque-type psoriasis, and treatment of initial genital herpes episodes, with shortened time to healing.

In postoperative gynecology surgery patients with wound complications, standard wound care was superior to aloe vera. It was concluded that evidence regarding would healing was contradictory.

All studies had methodologic flaws and did not achieve high scores for quality of the study design. Flaws included lack of randomization, lack of blinding, small sample size, lack of intention to treat analysis, and lack of power calculations.

Trials tended to originate from the same research groups, and independent replications were lacking. As a result, firm conclusions from the review cannot be drawn.

Oral aloe vera may have had some effect in reducing blood glucose levels in combination with antidiabetic therapy and in influencing lower serum lipids in one study.

Conclusions:

No firm conclusions were drawn from the review because of multiple methodologic studies. It was concluded that topical application does not seem to prevent radiation-induced skin damage. No statistical significance findings from studies were reported.

Limitations:

The authors only included abstracts of controlled trials but then drew no conclusions about these findings because they were only abstracts.

Nursing Implications:

More and better clinical trial data are needed to define the clinical effectiveness of this remedy.

Purpose & Patient Population:

PURPOSE: To develop evidence-based guidelines to prevent and treat skin toxicity (acute and late) from radiation therapy. Use of these guidelines was intended for practitioners who encounter patients with skin changes associated with radiation therapy.

TYPES OF PATIENTS ADDRESSED: Patients who have received or will receive radiation therapy

Type of Resource/Evidence-Based Process:

RESOURCE TYPE: Evidence-based guideline

PROCESS OF DEVELOPMENT: The Skin Toxicity Study Group is one of 17 study groups of the Multinational Association for Supportive Care in Cancer (MASCC). The first original search was from 1980–2004 and was used by the Cancer Care Ontario guideline group. This search was updated in 2010 for a book chapter on radiation dermatitis, including the original search strategy from 1980–2004 in addition to a search without language restriction for 2004–August 2010. For the MASCC guideline, a second update from 2010–April 2011 was conducted for the meeting. A final update was completed in July 2012 prior to publication of the manuscript.

DATABASES USED: MEDLINE for initial and subsequent updates; PreMEDLINE, Cochrane Library, and CANCERLIT for the original search 1980–2004; Embase for 2010–2012; and conference proceedings of the American Society of Clinical Oncology for 2004–2012. National Guidelines Clearinghouse was used for existing practice guidelines.

KEYWORDS: Radiation dermatitis for acute reactions; telangiectasia and cutaneous fibrosis for late reactions

INCLUSION CRITERIA: Randomized controlled trials, guideline papers, meta-analyses, and systematic reviews. Studies that included any control group met the definition of a controlled study. Inclusion required that grade of skin reaction was evaluated as an outcome with primary interest greater or equal to moist desquamation. Pain, itching, and quality of life also were included if available. For late reaction dermatitis, trials using prospective designs were used.

EXCLUSION CRITERIA: Unpublished articles

Phase of Care and Clinical Applications:

PHASE OF CARE: Multiple phases of care

Results Provided in the Reference:

Acute radiation dermatitis recommendations were based on guidelines consisting of four general systematic reviews, two for specific topics, two evidence-based guidelines, and one consensus guideline. There were 56 randomized controlled trials–45 prevention, 9 treatment, and 1 combined prevention and treatment. Late radiation effect recommendations were based on one RCT; one prospective, observational study; and two prospective, single-arm studies.

Weak recommendation against pentoxifylline for reduction of fibrosis in standard clinical practice

Patient education materials:

Validation prior to use

Sixth grade reading level and tables preferred

Specific products to purchase with examples

Behaviors to avoid

Contact information for physician and when to call for symptom management

Nursing Implications:

Nurses need to keep updated on current studies and guidelines related to care of patients receiving radiation therapy as well as potential acute and long-term effects to the skin. Nurses are in a unique position to educate staff and patients on evidenced-based skin care. Potential skin care practices for patients undergoing radiation need to be evaluated through well-designed research studies.